JP2008125760A - Sterilizing bag - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an environment-friendly sterilizing bag which is used for the sterilization of medical equipment, employs laminated paper in place of a synthetic film thereby suppressing amount of use of petrochemicals and enables both of the paper and the film to be recycled as resources when they are separated from each other. <P>SOLUTION: The invention relates to the sterilizing bag for the sterilization of the medical equipment is disclosed, especially the one of a combination type in which the peripheral edge parts of sterilizing paper and the synthetic film are heat-sealed with each other to form the bag, and the sterilizing bag is characterized in that it is formed by heat-sealing the laminated paper instead of the synthetic film and the sterilizing paper, the laminated paper being obtained by laminating the paper and a thermoplastic resin. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

The present invention relates to a sterilization packaging material used for sterilization of medical equipment, and relates to sterilized paper and a sterilization bag using the same.

Medical devices such as syringes, tweezers, scalpels, scissors, etc. used for surgery and treatment must be sterilized before use, and the items to be sterilized such as medical devices are stored in a sterile bag. And sterilized. For example, sterilization methods implemented in hospitals include heating methods (high-pressure steam sterilization methods, dry heat methods, etc.), irradiation methods (gamma rays, electron beams, etc.), gas methods (ethylene oxide gas method, hydrogen peroxide gas plasma). Sterilization treatment is performed by any of the above methods.

Regarding the sterilization bag, according to the explanation of Non-Patent Document 1, there is no pore exceeding 0.4 μm, and the air permeability (JIS P8117) is about 20 to 500 seconds. To do. Some sterilization bags have sterilized paper folded or two stacked to seal the periphery, but in that case, the contents cannot be seen from the outside.

Therefore, the sterilization bag adapted to the high-pressure steam sterilization method by heating method and the ethylene oxide gas method and the hydrogen peroxide gas plasma method in the gas method allows the passage of steam and gas, and sterilized paper that blocks or captures bacteria and gas permeation A synthetic resin film having a low degree is generally produced by heat-sealing the peripheral portions of both. The mainstream is a type in which the sealed object to be sterilized is sterilized, and the object to be sterilized can be seen through from the film side.

The synthetic resin film used in the sterilization bag is mainly a combination of a tough and excellent tensile strength polyethylene terephthalate film and a polypropylene film that is flexible and has high tear strength and is used as a sealant for heat sealing with paper. is there.

In the above sterilization bag, it is difficult to print the indicator ink indicating the completion of the sterilization process on the film surface, so it is printed on the sterilized paper side. Therefore, the sterilization process is completed with the discoloration of the indicator ink printed on the sterilized paper. After confirming the above, the bag had to be turned over to confirm the sterilized material, and the operation was complicated. In addition, since the material is made of synthetic resin, there is a demand from the environmental aspect to increase the proportion of paper.

In addition, patents relating to sterilization bags and sterilized papers already include Patent Documents 1 to 12 and the synthetic film base material that is heat-sealed with the sterilized papers mentioned in these patents is polyethylene terephthalate, polyethylene naphthalate, polybutylene terephthalate. Polyester such as polyethylene, polypropylene, polystyrene, polyamide such as nylon-6, nylon-66, polycarbonate, polyacrylonitrile, polyvinyl chloride, polyimide, polyvinylidene chloride, ethylene / vinyl alcohol copolymer, polyvinyl alcohol, An unstretched or stretched film of ethylene-vinyl alcohol copolymer, polyether sulfone, polymethyl methacrylate, etc., and these copolymers, polyethylene, polypropylene, This is a synthetic film that combines heat-sealable substrates of unstretched films such as nomers and ethylene / vinyl acetate copolymer resins, and is used in an environment that uses laminated paper in which some of the components of the synthetic film are replaced with paper. There were no patents to consider.
JP 09-290808 A JP 2000-084054 A JP 2000-107268 A Japanese Patent Application Laid-Open No. 2000-200493 JP 2001-070414 A JP 2001-122348 A JP 2004-016680 A JP 2004-073723 A JP 2004-121838 A Japanese Patent Application Laid-Open No. 2004-229692 JP 2005-307358 A JP 2005-335882 A Tech Times: latest paper processing manual 782-P. 783

It is an object of the present invention to provide an environmentally friendly sterilization bag that is easy to read indicator printing.

(1) A sterilization bag obtained by laminating a laminate paper and a sterilized paper obtained by laminating paper and a synthetic resin film, and heat-sealing the peripheral edge.

(2) The sterilized bag according to (1), wherein the paper of the laminated paper has an opacity of 40% or less (JIS P8138), and the contents of the sterilized bag can be identified from the laminated paper side.

(3) The sterilization according to (1) or (2), characterized in that an indicator ink for indicating completion of sterilization is printed on the laminated paper according to either (1) or (2) bag.

The present invention makes it possible to reduce the amount of synthetic resin film, which is a petrochemical product of a sterilization bag used for medical equipment, and to separate both paper and film so that both can be used as resources. It can be expected as an easy sterilization bag. In addition, it has become possible to easily print indicator ink on the film side on the paper side of the laminated paper, which has been difficult in the past. Therefore, after confirming the completion of the sterilization process by confirming the discoloration of the indicator ink printed on the conventional sterilized paper, the troublesome operation of turning the bag over and checking the object to be sterilized is unnecessary. The sterilized product can be confirmed.

In order to achieve the above object, the paper must be transparent so that an object to be sterilized can be identified. Therefore, the opacity is desirably 40% or less.

In order to increase the transparency of the paper, it is necessary to suppress irregular reflection that blocks the transmission of light into the paper layer. As a countermeasure, there is a method of impregnating the paper with a clearing agent or increasing the density of the paper.

When impregnating with a clearing agent, use a clearing agent because the glass transition point of the clearing agent is low, and it may adhere to the cylinder dryer during drying after coating, causing dirt and defects. In some cases, coating by an off coater is common.

As a method of increasing the density of the paper, a method of promoting beating to promote fibrillation by proceeding with beating, or supercalender treatment at high temperature and high linear pressure in a state where the paper has a high moisture content of 30% or more. There are methods of applying or combining the two.

One method of making the raw material fine is to select the pulp raw material to be used. NBKP (coniferous tree) has larger fibers and is more easily fibrillated than LBKP (broadleaved tree), so there are few voids between the fibers (light irregular reflection is low and transparency is high). Therefore, although it is desirable to use 100% of NBKP, LBKP may be appropriately blended because there is a possibility of running out of water and poor formation during paper making. The beating freeness is preferably 100 ml CSF or less.

In super-calender processing with high moisture, it is important to manage the temperature, linear pressure, and processing speed in order to obtain the desired density. Thickness due to uneven crushing in the width direction and generation of wrinkles due to undried parts after processing It is necessary to consider such things. In order to suppress the thickness after the super calender process, it is necessary to keep the moisture profile in the width direction on the machine reel as uniform as possible.

As a feature of high-density paper, the strength depending on the bond between fibers, such as the tensile strength in dry paper, is high, but the tear strength and the strength of the paper when wet are apt to decrease. This is a severe condition for high density paper that is exposed to steam under high pressure for a certain period of time. In the next section, in the high-pressure steam sterilization method, a method of maintaining the state before the sterilization treatment in appearance after being exposed to water vapor for a certain time under high pressure will be described.

The sterilization bag of the present invention is a bag in which a film made of a sealant and paper are bonded to form a laminated paper and sterilized paper are heat-sealed. As described above, high-density paper has very low tear strength and wet strength. As a typical synthetic film base material, a material having strong strength such as polyethylene terephthalate (base material 1) is used, but on the other hand, there is a disadvantage that the tear strength is weak. By combining such a flexible thermoplastic resin (base material 2) that is excellent in tear strength and effective as a sealant, a device has been devised to make use of each other's advantages.

A high-density paper is excellent in strengths other than the tear strength at the time of dry paper like the base material of the synthetic film. As in the case of the synthetic film, the present inventor considered that the tear strength of the paper and the brittleness of the paper when wet were compensated with the thermoplastic resin as the sealant, and the lack of the tensile strength of the thermoplastic resin could be supplemented with the paper. By laminating paper and thermoplastic resin, it was estimated that the performance capable of withstanding high-pressure steam sterilization was developed, and the following examples were verified.

When laminating high-density paper and thermoplastic film, wet lamination methods that mainly use water-based adhesives can cause dimensional changes such as wrinkles due to the swelling of the paper before drying the adhesive, and can be laminated evenly. The dry lamination which is considered difficult and is bonded after the adhesive is dried is preferable. Also, a method of laminating polyethylene resin already melted on glassine paper like medicine wrapping paper by the extrusion method, for example, ethylene vinyl acetate, vinyl chloride vinyl acetate, polyacrylic acid ester etc. are dispersed in water or dissolved in organic solvent A casting method in which the thermoplastic resin is laminated on the paper by coating is also conceivable.

Usually, in order to confirm the completion of the sterilization process, in addition to the indicator ink printed on the sterilized paper, a portable indicator capable of confirming the completion of the sterilization process in the sterilization bag is enclosed in the sterilization bag together with the article to be sterilized.

Therefore, as with the synthetic film, the opacity of the laminated paper is preferably 15% or less so that the color change determination of the indicator can be identified from the laminated paper side. Further, the type and thickness of the paper and the raw materials constituting the paper are not limited.

When printing the indicator ink on paper, it is desirable to provide it on the opposite side of the thermoplastic resin for the following reasons. That is, there is a risk that the indicator ink sharpness, chemical reaction with the adhesive, discoloration failure due to insufficient gas permeation, ink melts during sterilization, and penetrates through the thermoplastic resin as a sealant and transfers to a medical device. . The thickness of the thermoplastic resin to be used is determined by the application and is not particularly limited.

Indicator ink should be an ink that changes color by heating method (high pressure steam sterilization method, dry heat method, etc.), irradiation method (gamma ray, electron beam, etc.), gas method (ethylene oxide gas method, hydrogen peroxide gas plasma method, etc.). For example, the ink material is not particularly limited.
Further, depending on the sterilization method, one or two or more inks serving as indices may be combined.

The indicator ink can be printed by gravure printing, but other examples include offset printing and flexographic printing.

The constituent material of sterilized paper consists of paper and non-woven fabric. In the case of paper, the raw material is pulp fiber made of wood and plants,
The raw material in the case of the nonwoven fabric may be a synthetic resin such as polyester, rayon, nylon, polypropylene, vinylon, polyethylene, acrylonitrile, polyurethane and the like. Further, a mixed paper obtained by mixing pulp fiber and synthetic resin is also conceivable. In addition, it does not specifically limit by uses, such as basic weight and thickness.

The form of the sterilization bag includes a flat or gusset roll or a single-wafer type or a three-side-sealed single-wafer type in which side ends of 5 to 20 mm are side-sealed in advance depending on the convenience and use of each medical institution.

Hereinafter, the sterilization bag of the present invention will be described in detail by way of examples. The sterilized papers to be heat-sealed in the examples and comparative examples are all of the same manufacturing method, the mixing ratio of NBKP pulp and LBKP pulp is 1: 1, beating freeness is 450 CSF ml, alkyl ketene dimer (size pine K as neutral sizing agent) -903 / Arakawa Chemical Co., Ltd.) for pulp 0.3%, Polyamide polyamine epichlorohydrin resin (Arafix 255 / Arakawa Chemical Co., Ltd.) as a wet paper strength enhancer 1% for pulp In addition, polyamide paper (Polystron 117 / manufactured by Arakawa Chemical Co., Ltd.) is used as a paper paper strength enhancer, and paper is made by a wet paper making method with 1% of pulp, and a styrene acrylic resin (Polymaron 1308S /) is used as a surface coating agent. Arakawa Chemical Industries, Ltd.) was applied with a two-roll size press to obtain sterile paper with basis weights of 60 g / m ² and 70 g / m ² . In addition, the indicator paper for high-pressure steam sterilization and ethylene oxide gas is printed on the sterilized paper by gravure printing.
(Example 1)

Hand-pasted a 30μm thick cast polypropylene (unstretched polypropylene by T-die method, hereinafter abbreviated as “CPP”) onto glassine paper with a basis weight of 30.5 g / m ² (opacity of about 25%). The CPP part of the laminated paper bonded together with the sterilized paper having a basis weight of 60 g / m ² was heat-sealed at both ends 10 mm to obtain a sterilized bag.
(Example 2)

A CPP part of a laminated paper obtained by manually bonding a CPP having a thickness of 30 μm to a glassine paper having a basis weight of 40 g / m ² (opacity of about 35%) with a solvent-based adhesive and the sterilization having a basis weight of 60 g / m ² The paper was heat sealed at both ends 10 mm to obtain a sterilization bag.
(Example 3)

High beating glassine paper opacity about 10% of the basis weight of 30.5 g / ^{m 2} the CPP thickness 30μm in (Graffin / Oji Specialty Paper Co.) bonded by the adhesion hand with a solvent-based adhesive was laminated paper The CPP part and the sterilized paper having a basis weight of 60 g / m ² were heat sealed at both ends to obtain a sterilized bag.
Example 4

Gravure printing of high pressure steam sterilization and indicator ink for ethylene oxide gas (manufactured by Sakata Inx Co., Ltd.) was performed on a grafan having a basis weight of 35 g / m ² . A non-printed surface of the graphane and a CPP portion of a laminated paper obtained by laminating a CPP having a thickness of 30 μm with a solvent-based adhesive and a sterilized paper having a basis weight of 70 g / m ² are heat-sealed at both ends by 10 mm to obtain a sterilization bag. Obtained.
(Example 5)
Gravure printing of high pressure steam sterilization and indicator ink for ethylene oxide gas (manufactured by Sakata Inx Co., Ltd.) was performed on a grafan having a basis weight of 35 g / m ² . A CPP portion of a laminated paper obtained by laminating a printed surface of the graphane and a CPP having a thickness of 30 μm with a solvent-based adhesive and a sterilized paper having a basis weight of 70 g / m ² are heat sealed at both ends to obtain a sterilized bag. It was.

(Comparative Example 1)

A CPP portion of a synthetic film composed of PET having a thickness of 12 μm and CPP having a thickness of 30 μm and the sterilized paper having a basis weight of 70 g / m ² were heat sealed at both ends to obtain a sterilized bag.

(Evaluation of sterilization bag performance) A portable indicator was sealed in the sterilization bags obtained in Examples 1 to 5 and Comparative Example 1, and the steam temperature was 135 ° C and the treatment time was 30 minutes. Sterilization with high-pressure steam sterilization or ethylene oxide gas including 5 cycles at times and 1 cycle at the end was performed.

Visually determined the ease of discriminating the discoloration of the indicator ink printed on the graphane of the sterilized bag after sterilization treatment obtained in Examples 4 to 5 as the evaluation criteria ◯ based on the clarity of the indicator ink printed on the sterilized paper. According to the evaluation, the inferior one was evaluated as △ and the excellent one was evaluated as ◎ in three stages.

Through the sterilization bag after the sterilization treatment obtained in Examples 1 to 5 through the laminated paper side, the ink discoloration of the portable indicator is visually performed, and the distinguishability from the synthetic film side of Comparative Example 1 is set to 5, Evaluation was made in five stages.
5: Transparent and clearly identified.
4: Can be identified without problems.
3: Slightly difficult to see but can be identified.
2: Light characters may not be visible.
1: Cannot be identified.

The damage of the sterilized bag of the sterilized bag obtained in Examples 1 to 5 was evaluated by visual judgment as ◯ if no change was observed before and after the treatment, and when there was deterioration, △ was evaluated in two steps. .

The peelability of the sterilized bags obtained in Examples 1 to 5 was peeled from the sterilized paper after the high-pressure steam sterilization treatment, and the peelability after the high-pressure steam sterilization treatment of Comparative Example 1 was the best ◎. The amount of paper powder transferred to was evaluated in three stages by visual judgment, with a slightly inferior one being ◯ and an inferior one being △. The results are shown in the table. In the table, AC represents high-pressure steam sterilization using an autoclave, and EOG represents gas sterilization using ethylene oxide gas.

The damage of the sterilized bag of the sterilized bag obtained in Examples 1 to 5 was evaluated by visual judgment as ◯ if no change was observed before and after the treatment, and when there was deterioration, △ was evaluated in two steps. .

As an environmental evaluation, the environmental load was defined by the weight ratio of the petrochemical product in the entire sterilized bag, the weight ratio of Comparative Example 1 was set as x, and the halved one was evaluated in two stages.

As is apparent from the table, the performance is comparable to the sterilization bag of Comparative Example 1 currently used, except that it is slightly inferior to the color change identification of the portable indicator.

As described above, it was proved by the Examples that the sterilization bag of the present invention in which the synthetic film as a constituent material of the current sterilization bag is replaced with laminated paper is equivalent to the current sterilization bag in terms of performance. In addition, the weight ratio of petrochemical products constituting the sterilization bag to the entire bag is halved, and the burden on the environment is reduced compared to the current sterilization bag.

Claims (3)

A sterilization bag obtained by laminating a laminate surface of a laminate paper obtained by laminating paper and a synthetic resin film and sterilized paper, and heat-sealing the peripheral edge. The sterilized bag according to claim 1, wherein the laminated paper has an opacity of 40% or less (JIS P8138), and the sterilized bag contents can be identified from the laminated paper side. The sterilization bag according to claim 1 or 2, wherein an indicator ink for indicating completion of sterilization is printed on the laminated paper according to any one of claims 1 and 2.